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Register:	ISRCTN
Last refreshed on:	25 March 2019
Main ID:	ISRCTN11877362
Date of registration:	25/11/2005
Prospective Registration:	No
Primary sponsor:	World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Public title:	A phase II, double-blind, randomised, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of three doses of GlaxoSmithKline (GSK) Biologicals? oral live attenuated human rotavirus (HRV) vaccine (RIX4414 at 106.5 CCID50) administered to human immunodeficiency virus (HIV) infected infants at 6, 10 and 14 weeks of age in South Africa
Scientific title:	A phase II, double-blind, randomised, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of three doses of GlaxoSmithKline (GSK) Biologicals? oral live attenuated human rotavirus (HRV) vaccine (RIX4414 at 106.5 CCID50) administered to human immunodeficiency virus (HIV) infected infants at 6, 10 and 14 weeks of age in South Africa
Date of first enrolment:	01/01/2004
Target sample size:	100
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN11877362
Study type:	Interventional
Study design:	Phase II double-blind randomised placebo-controlled study (Treatment)
Phase:	Phase II

Countries of recruitment
South Africa

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Duncan Steele
Address:	20, Avenue Appia CH 1211 Geneva-27 Switzerland
Telephone:	+41 (0)227913752
Email:	steeled@who.int
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Parents/guardians of subjects who could comply with the protocol requirements (e.g. completion of diary cards, return for follow-up visits)
2. Male or female 6 - 10 weeks of age at the time of first vaccination
3. Written informed consent from parents/guardians
4. Documented HIV status of the subject as confirmed by Polymerase Chain Reaction (PCR)
5. HIV asymptomatic and HIV mildly symptomatic
6. Categories N and A according to CDC HIV clinical classification
7. Born after a gestation period of 36 - 42 weeks

Exclusion criteria:
1. Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period
2. Previous routine vaccination except Bacillus Calmette-Guerin (BCG) and hepatits B virus (HBV)
3. Clinically significant history of chronic gastrointestinal tract (GIT) disease including any incorrected congenital malformation of GIT
4. History of allergic disease or reaction likely to be exacerbated by any component of the vaccine
5. Acute illness at the time of enrolement
6. Diarrhea with in 7 days preceding the study vaccination
7. Administration of immunoglobulins and/or blood products since birth or planned during study period
8. Use of any investigational or non-registered drug or vaccine other than study vaccines during the study period

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Vaccine/immunisation
Infections and Infestations
Vaccination

Intervention(s)

Intervention: three doses of GSK Biologicals? oral live attenuated human rotavirus (HRV) vaccine (RIX4414) at 106.5 CCID50 viral concentration
Control: placebo

Primary Outcome(s)

Percentage of subjects who report grade "2" or grade "3" fever, vomiting or diarrhoea during the 15-day f/u period after each dose.

Secondary Outcome(s)

1. Reactogenicity
2. Serious adverse events (SAEs)
3. CD4 count and human immunodeficiency virus (HIV) viral load at screening and visit 4
4. Immunogenicity
5. Rotavirus shedding until ceases
6. Enteric pathogens
7. Immunogenicity of antigens contained in concomitantly administered routine vaccine DTPw-HBV/Hib + OPV

Secondary ID(s)

444563-022

NCT00263666

Source(s) of Monetary Support

RAPID trials (USA), World Health Organization (WHO) (Switzerland)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethics approval received in 2004.

Results

Results available:	Yes
Date Posted:
Date Completed:	01/01/2006
URL:

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